TY - JOUR
T1 - Is Intravenous Immunoglobulin Effective in Reducing the Risk of Mortality and Morbidity in Neuroinvasive West Nile Virus Infection?
T2 - A Critically Appraised Topic
AU - Mbonde, Amir A.
AU - Grill, Marie F.
AU - Harahsheh, Ehab Y.
AU - Marks, Lisa A.
AU - Wingerchuk, Dean M.
AU - O'Carroll, Cumara
N1 - Funding Information:
The authors ought to be commended for publishing a negative trial, which is important as this mitigates the risk of publication bias and provides a basis upon which future similar clinical trials can be modified to allow for more informed investigation. The authors should also be commended for undertaking a study in which cases are seasonal and geographically widespread. Therefore, strict coordination between the study sites was needed to accrue the required number of participants for the study’s sample size. The investigators are also to be commended for astutely recording all side effects regardless of potential relation to the medications, and further determining those with a possible relationship. Furthermore, the assessment of the outcomes was robust and was completed using highly reliable tools such as the mRS and GOS that have been widely validated for use in different neurological diseases. In addition to using reliable tools for assessing the study outcomes, the investigators also ensured that all enrolled participants had a laboratory confirmed diagnosis of WNV disease (neuroinvasive or non-neuroinvasive). Although the study drug was provided by OMRIX Biopharmaceuticals Ltd. (Tel Aviv), the trial was predominantly supported by a contract from the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (N01A130025), thereby minimizing bias that may be introduced by industry-funded clinical trials. Although, it is technically still possible to have some potential for industry influence on the study.
Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/3/30
Y1 - 2023/3/30
N2 - Background: The clinical benefit of intravenous immunoglobulin (IVIG) in adult individuals with neuroinvasive West Nile virus (niWNV) infection is not well substantiated. We sought to critically assess current evidence regarding the efficacy of IVIG in treating patients with niWNV. Methods: The objective was addressed through the development of a critically appraised topic that included a clinical scenario, structured question, literature search strategy, critical appraisal, assessment of results, evidence summary, commentary, and bottom-line conclusions. Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of neuro-infectious diseases. Results: The appraised study enrolled 62 participants with suspected niWNV, randomized into 3 different arms [37 participants in the Omr-IgG-am group, 12 in the Polygam group, and 13 in the normal saline (NS) group]. Omr-IgG-am and Polygam are different formulations of IVIG. IVIG safety, measured as rates of serious adverse events, was the primary study outcome while IVIG efficacy, measured as rates of unfavorable outcomes, was a secondary endpoint. The estimated rates of SAE were statistically similar in all groups (51.4% Omr-IgG-am, 58.3% Polygam, and 23.1% NS groups). Unfavorable outcomes also occurred at a similar rate between all the groups (51.5% Omr-IgG-am, 54.5% Polygam, and 27.3% NS). Conclusions: The appraised trial showed that Omr-IgG-am and Polygam are as safe as NS. Data on efficacy from this trial were limited by a small sample size. Phase III clinical trials on IVIG efficacy in NiWNV infection are needed.
AB - Background: The clinical benefit of intravenous immunoglobulin (IVIG) in adult individuals with neuroinvasive West Nile virus (niWNV) infection is not well substantiated. We sought to critically assess current evidence regarding the efficacy of IVIG in treating patients with niWNV. Methods: The objective was addressed through the development of a critically appraised topic that included a clinical scenario, structured question, literature search strategy, critical appraisal, assessment of results, evidence summary, commentary, and bottom-line conclusions. Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of neuro-infectious diseases. Results: The appraised study enrolled 62 participants with suspected niWNV, randomized into 3 different arms [37 participants in the Omr-IgG-am group, 12 in the Polygam group, and 13 in the normal saline (NS) group]. Omr-IgG-am and Polygam are different formulations of IVIG. IVIG safety, measured as rates of serious adverse events, was the primary study outcome while IVIG efficacy, measured as rates of unfavorable outcomes, was a secondary endpoint. The estimated rates of SAE were statistically similar in all groups (51.4% Omr-IgG-am, 58.3% Polygam, and 23.1% NS groups). Unfavorable outcomes also occurred at a similar rate between all the groups (51.5% Omr-IgG-am, 54.5% Polygam, and 27.3% NS). Conclusions: The appraised trial showed that Omr-IgG-am and Polygam are as safe as NS. Data on efficacy from this trial were limited by a small sample size. Phase III clinical trials on IVIG efficacy in NiWNV infection are needed.
KW - critically appraised topic
KW - encephalitis
KW - intravenous immunglobulins
KW - meningioencephalitis
KW - meningitis
KW - West Nile virus
UR - http://www.scopus.com/inward/record.url?scp=85149771178&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85149771178&partnerID=8YFLogxK
U2 - 10.1097/NRL.0000000000000479
DO - 10.1097/NRL.0000000000000479
M3 - Article
C2 - 36728647
AN - SCOPUS:85149771178
SN - 1074-7931
VL - 28
SP - 129
EP - 134
JO - Neurologist
JF - Neurologist
IS - 2
ER -